Indigo System

GUDID 00815948021631

Aspiration Catheter 7, 50cm XTORQ Kit

PENUMBRA, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter
Primary Device ID00815948021631
NIH Device Record Key1e98dc52-1c5c-4c37-871b-bd03b2f61a90
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndigo System
Version Model NumberCAT7XTORQ50KIT-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]
GS100815948021631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

On-Brand Devices [Indigo System]

00814548017594Separator 4
00814548017587044 Coronary Aspiration Catheter 160 cm Kit
00814548017556044 Coronary Aspiration Catheter 140 cm Kit
00814548017440Indigo Separator 8
00814548016290Asp Cat 8, 115cm XTORQ
00814548016283Asp Cat 8, 115cm STR
00814548016276Asp Cat 8, 100cm XTORQ
00814548016269Asp Cat 8, 85cm STR
00814548016252Asp Cat 8, 85cm TORQ
00814548016245Aspiration Catheter 6
00814548016221Indigo 110 Asp Tubing CE
00814548016214Indigo 110 Asp Tubing
00814548016153Separator 8
00814548016146Separator 6
00814548016122Indigo Aspiration Tubing
00814548016115Separator 3
00814548016108Separator 5
00814548016092Asp Catheter 5, 132cm
00814548016085Asp Catheter 3
00814548016078Asp Catheter 4
00814548016061Asp Catheter 2
00814548016054Separator 2
00814548016047Separator 4
00814548013336Indigo Aspiration Tubing
00814548013329Separator 5
00814548013312Separator 3
00814548013305Asp Catheter 5, 132cm
00814548013299Aspiration Catheter 3
00815948020542Indigo CAT 5 Kit
00815948020535Asp Catheter 3 Kit
00815948020450Asp Cat 8, 115cm XTORQ Kit
00815948020436Asp Cat 8, 85cm STR Kit
00815948020412Asp Cat 8, 85cm TORQ Kit
00815948020405Aspiration Catheter 6 Kit
00815948020375Indigo 110 Aspiration Tubing
00815948022508Asp Cat 8, 85cm TORQ Kit
00815948022492Asp Cat 8, 85cm STR Kit
00815948022485Asp Cat 8, 115cm XTORQ Kit
00815948022478Asp Cat 8, 115cm XTORQ
00815948022461Asp Cat 8, 115cm STR
00815948022454Asp Cat 8, 100cm XTORQ
00815948022447Asp Cat 8, 85cm STR
00815948022430Asp Cat 8, 85cm TORQ
00815948022546CAT8 115 XTORQ Plus Lightning
00815948022539CAT8 115 XTORQ Plus Lightning
00815948022324Aspiration Catheter 8 115cm XTorq Kit
00815948022300Ind Asp Cat 8, 115cm-XTORQ
00815948022294Aspiration Catheter 8, 85cm TORQ Kit
00815948022270Ind Asp CAT8, 85cm-TORQ
00815948022263Aspiration Catheter 8, 85cm STR Kit

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